Abstract:
:The involvement of minors in clinical research is inevitable to catch up with the lack of drugs labeled for pediatric use. To encourage the responsible conduct of pediatric clinical trials in the EU, an extensive legal framework has been developed over the past decade in which the practical, ethical, legal, social, and commercial issues in pediatric research are addressed. In this article, the European legal framework surrounding pediatric clinical trials is analyzed from the perspective of the major ethical concerns in pediatric research. The four principles of biomedical ethics will be used as a conceptual framework (1) to map the ethical issues addressed in the European legal framework, (2) to study how these issues are commonly handled in competent adults, (3) to detect workability problems of these paradigmatic approaches in the specific setting of pediatric research, and (4) to illustrate the strong urge to differentiate, specify, or adjust these paradigmatic approaches to guarantee their successful operation in pediatric research. In addition, a concise comparative analysis of the European regulation will be made. To conclude our analysis, we integrate our findings in the existing ethical discussions on issues specific to pediatric clinical research.
journal_name
Eur J Pediatrjournal_title
European journal of pediatricsauthors
Pinxten W,Dierickx K,Nys Hdoi
10.1007/s00431-008-0915-7subject
Has Abstractpub_date
2009-10-01 00:00:00pages
1225-34issue
10eissn
0340-6199issn
1432-1076journal_volume
168pub_type
杂志文章abstract:UNLABELLED:To assess the efficacy of a serotonin re-uptake inhibitor, sertraline hydrochloride, in preventing recurrent neurocardiogenic syncope, we studied 15 patients (10 female; mean age 12.9 +/- 2 years) with positive head-upright tilt test and resistant to standard pharmacotherapy, atenolol or disopyramide. The pa...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s004310050704
更新日期:1997-10-01 00:00:00
abstract::We report two Chinese boys with Wiskott-Aldrich syndrome presenting with gastro-intestinal bleeding, eczema and recurrent infection. They had thrombocytopenia and the mean platelet volume was small. Serum IgG and IgA were elevated and lymphocyte proliferation in response to phytohaemagglutinin, concanavalin A and poke...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF01957573
更新日期:1992-09-01 00:00:00
abstract::A 15-year-old girl was admitted with a high fever and progressive malaise, vomiting, anorexia and abdominal complaints. She previously had a sore throat and unilateral painful swollen lymph nodes in the neck. Laboratory investigation indicated a bacterial infection. Blood cultures were taken. There was infiltrate in t...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-007-0628-3
更新日期:2008-06-01 00:00:00
abstract::The aim of this study is to evaluate and compare mothers' and grandparents' feeding behaviours, the differences between the behaviours, the relationship between children's feeding problems and grandparents' feeding behaviours, as well as the relationship between grandparents' feeding behaviour and children's body mass...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-018-3244-5
更新日期:2018-12-01 00:00:00
abstract::The relationship between nicotine and cotinine concentrations in mother's milk (including 24 h profiles) and the number of cigarettes consumed was studied. A total of 206 milk samples were collected from 34 nursing, smoking mothers. The mothers were distributed into three groups: Group I (1-10 cigarettes/day), group I...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF00647276
更新日期:1987-01-01 00:00:00
abstract:UNLABELLED:Isolated partial 3-methylcrotonyl-CoA carboxylase (MCC) deficiency has been described to be the cause for a distinct relatively mild clinical picture in a single patient. We describe another patient with isolated partial MCC deficiency who suffered from failure to thrive, muscular hypotonia and progressive r...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s004310050800
更新日期:1998-03-01 00:00:00
abstract:UNLABELLED:Mycobacterium bovis Bacillus Calmette-Guerin (BCG) is an attenuated live vaccine that may cause life-threatening clinical disease in children with impaired immunity. In particular, patients with any of the nine known inherited disorders of the interleukin-12/23 interferon-gamma (IL-12/23-IFNgamma) axis are h...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-004-1599-2
更新日期:2005-03-01 00:00:00
abstract:BACKGROUND:The treatment of complicated urinary tract infection in children is still a matter of debate. In our hospital, antimicrobial treatment is initiated intravenously, and the duration of this treatment is adapted according to the results of a Tc-99m dimercaptosuccinic acid (DMSA) scintigraphy. AIM:This study wa...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-013-2024-5
更新日期:2013-09-01 00:00:00
abstract::We aimed to demonstrate the value of monitoring infants with arteriovenous malformation (AVM) during endovascular embolization with integrated evaluation of hemodynamics (IEH) and guiding decisions according to the underlying pathophysiology. This is a retrospective analysis of the perioperative hemodynamics data for ...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-020-03735-z
更新日期:2021-01-01 00:00:00
abstract:UNLABELLED:Sjögren syndrome (SS) is a common disorder in adults and involves both glandular and extraglandular systems. We report here four cases of childhood SS complicated by chronic thyroiditis, interstitial nephritis or sweat gland inflammation. Additionally, in one of these cases, the central nervous system was in...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF02282840
更新日期:1996-10-01 00:00:00
abstract::Cortisol and growth hormone (GH) secretion (spontaneous variations at night and the release induced by insulin hypoglycaemia) were investigated in 69 children and adolescents. Statistical analysis of approximately 600 pairs of cortisol and GH values in this study demonstrated that physiological fluctuations of cortiso...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF00496996
更新日期:1978-06-20 00:00:00
abstract::A mother carrying a fetus affected with 21-hydroxylase deficiency received prenatal treatment with dexamethasone (0.5 mg, tid, p.o.) started from the very beginning of the 8th week of gestation. Prenatal diagnosis had to rely on amniocentesis with karyotyping and steroid hormone determination, because HLA and DNA data...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF02190657
更新日期:1994-08-01 00:00:00
abstract::Medical clowns have an important role in helping patients cope with their pain and distress. This is especially true in the pediatric population. However, their activity in a disaster area is unheard of. Following the Nepal earthquake in 2015, the Israeli field hospital set up in Kathmandu, Nepal was joined by five vo...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-017-3018-5
更新日期:2018-02-01 00:00:00
abstract::Co-trimoxazole is an effective antibacterial agent for the prophylaxis of urinary tract infection. Because experimental evidence raises the possibility that high-dose cotrimoxazole might interfere with normal somatic growth, the longitudinal growth and growth velocities were analysed in 114 girls receiving long-term, ...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF00442669
更新日期:1983-09-01 00:00:00
abstract:UNLABELLED:In neonatology, the early prediction of length-of-stay (LOS) may help in decision making. We retrospectively studied the accuracy of two LOS prediction models, namely a multiple linear regression model (MR) and an artificial neural network (ANN). Preterm neonates (n = 2144) were randomly assigned to a traini...
journal_title:European journal of pediatrics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/s004310051010
更新日期:1999-01-01 00:00:00
abstract:UNLABELLED:Storage of human breast milk by freezing or refrigeration of milk with and without heating have been recommended. This can hardly be avoided because of the social circumstances of most mothers who are regularly separated from their infants because of work or schooling as well as the particular needs of some ...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s004310000577
更新日期:2000-11-01 00:00:00
abstract::Chemically defined or elemental medical foods provide the majority of protein equivalent in the diets of children treated for phenylketonuria (PKU). Because of the restricted intake of high biologic value protein, children with PKU often have lower than normal plasma concentrations of ferritin and zinc. Few reported s...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/pl00014231
更新日期:1996-07-01 00:00:00
abstract::Two children with congenital cytomegalovirus infection and intracerebral echogenicities were investigated by computer sonography and colour Doppler imaging (CDI). By simultaneous imaging of brain tissue and CDI, blood flow within the stripe-like echogenicities of the basal ganglia was demonstrated. Using CDI the echog...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF01959476
更新日期:1990-11-01 00:00:00
abstract::A benign cystic nephroblastoma in a 6-month-old boy is presented. Erroneous interpretation as malignant nephroblastoma led to unnecessarily aggressive therapy. There is no evidence of recurrence or metastatic disease 12 years after the initial resection. As shown in our case and in the others previously reported in th...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF00447474
更新日期:1979-05-18 00:00:00
abstract::We aimed to describe the experiences of children and adolescents with congenital heart disease (CHD). Electronic databases were searched until August 2016. Qualitative studies of children's perspectives on CHD were included. Data was extracted using thematic synthesis. From 44 studies from 12 countries involving 995 c...
journal_title:European journal of pediatrics
pub_type: 杂志文章,评审
doi:10.1007/s00431-017-3081-y
更新日期:2018-03-01 00:00:00
abstract::Severe complications due to Shigatoxin-associated hemolytic uremic syndrome (STEC-HUS) currently present a serious challenge since no specific treatment for this condition is available. Eculizumab, a terminal complement inhibitor, has been used especially in STEC-HUS patients with severe neurological involvement, but ...
journal_title:European journal of pediatrics
pub_type: 杂志文章,评审
doi:10.1007/s00431-017-3077-7
更新日期:2018-03-01 00:00:00
abstract::An adapted cow's milk formula with or without supplemental taurine (480 mumol/l) was fed for 16 weeks to 20 low-birth-weight infants. In the 2nd and 16th weeks of life, respectively, the following parameters were determined: growth, sonography of heart and brain, ECG, EEG, neurological development and the taurine conc...
journal_title:European journal of pediatrics
pub_type: 临床试验,杂志文章
doi:10.1007/BF00442699
更新日期:1988-04-01 00:00:00
abstract::Education is necessary to improve child physical abuse detection and management. A few studies have described national child abuse training programs, but none has measured changes in knowledge among participants. A collaboration of child abuse experts from the USA, an academic pediatric department, and a non-governmen...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-020-03625-4
更新日期:2020-09-01 00:00:00
abstract::Three infants with severe combined immunodeficiency and adenosine deaminase (ADA) deficiency were treated by T-cell depleted bone marrow transplantation (BMT), using human leukocyte antigen (HLA)-haploidentical parents as donors. In the first patient, two initial transplants failed to engraft and no change of the immu...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF01995857
更新日期:1989-11-01 00:00:00
abstract::Iliac vessel disruption following blunt trauma is an unusual presentation, particularly in the absence of an orthopaedic injury. We present the unique case of a 14-year-old boy who sustained a blunt bicycle handlebar impalement that resulted in complete transection of the external iliac artery and laceration of the ex...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-012-1767-8
更新日期:2012-12-01 00:00:00
abstract:UNLABELLED:Our aim was to determine whether the chest radiograph appearance at 7 days predicted chronic lung disease development (oxygen dependency at 36 weeks post-menstrual age) or death before discharge and if it was a better predictor than readily available clinical data. Two consecutive studies were performed. In ...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-003-1332-6
更新日期:2004-01-01 00:00:00
abstract::Iron deficiency is frequently associated with anemia. Iron is a transition-metal ion, and it can induce free radical formation, which leads to formation of various lesions in DNA, proteins, and lipids. The aim of this study was to investigate baseline oxidative DNA damage and to clarify the role of the administration ...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-010-1147-1
更新日期:2010-08-01 00:00:00
abstract::The clinical presentation of combined pituitary hormone deficiency (CPHD) is variable. Some patients present with hypoglycemia during the neonatal period or during the first few years of life. Others present later in childhood with growth failure. We report on 7 patients with very late diagnosed severe hypopituitarism...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/s00431-019-03489-3
更新日期:2020-01-01 00:00:00
abstract:UNLABELLED:We investigated the clinical and biochemical characteristics of a 6-year-old Japanese boy with very-long-chain acyl-CoA dehydrogenase (VLCAD) deficiency. He had hypoketotic hypoglycaemia, exercise- and fasting-induced lethargy, hepatomegaly and cardiomegaly. Significant laboratory findings included elevated ...
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/pl00008368
更新日期:2000-12-01 00:00:00
abstract::Recombinant human erythropoietin was given to eight children and adolescents with stable chronic renal failure in the predialysis state. The hormone was administered subcutaneously, twice weekly for 12 weeks, at a starting dose of 50 U/kg per week. The dosage was adapted every 4th week. Target haemoglobin was 10.5-11....
journal_title:European journal of pediatrics
pub_type: 杂志文章
doi:10.1007/BF01959224
更新日期:1994-02-01 00:00:00